threatened to remove vaping products from the market unless their manufacturers come up with satisfactory plans to prevent underage consumption. FDA Commissioner Scott Gottlieb acknowledged that the demand conflicts with efforts to promote vaping as a harm-reducing alternative to smoking. "Inevitably what we are going to have to contemplate are actions that may narrow the off-ramp for adults who see e-cigarettes as a viable alternative to combustible tobacco in order to close the on-ramp for kids," he told reporters. "It's an unfortunate tradeoff."Declaring that "youth use of e-cigarettes is reaching epidemic proportions," the Food and Drug Administration today
That tradeoff is not just unfortunate; it is morally unacceptable and scientifically suspect. Gottlieb is talking about reneging on the FDA's four-year extension of the deadline for seeking regulatory approval to continue selling e-cigarettes, which would wreak havoc with a market that he concedes has great potential for reducing smoking-related disease and death. Short of that, he suggests the FDA might force companies to stop offering e-liquid flavors that appeal to minors, which are an important factor in quit attempts by adult smokers. The premise of such threats is that the interests of adults who might want to switch from smoking to a far less hazardous form of nicotine consumption should be sacrificed for the sake of curtailing e-cigarette use by minors, which is already illegal.
The FDA says it has issued "more than 1,300 warning letters and fines to retailers" as a result of "a large-scale, undercover nationwide blitz to crack down on the sale of e-cigarettes to minors." But it also sent letters to five leading manufacturers of "electronic nicotine delivery systems" (ENDS), insisting that they do more to keep their products away from teenagers. The FDA is demanding what Gottlieb describes as "plans to immediately and substantially reverse" the "clear and present danger" of adolescent vaping.
The FDA's suggestions include rigorous age verification procedures for online direct sales (which Juul, the market leader, says it already has) and "discontinuing sales to retail establishments that have been subject to an FDA civil monetary penalty for sale of tobacco products to minors within the prior 12 months." But the agency also thinks ENDS makers should consider "revising your current marketing practices to help prevent use by minors" and "removing flavored products from the market until those products can be reviewed by FDA" as part of the pre-market approval process. While "Juul Labs will work proactively with FDA in response to its request," a company spokesperson says, "appropriate flavors play an important role in helping adult smokers switch." More generally, the FDA wants Juul and the other companies to contemplate "the particular youth appeal of their products," which involves features, such as style and convenience, that adults also happen to like.
Those broader recommendations would constrain the ability of e-cigarette companies to reach adult smokers and make ENDS less appealing to them. The upshot could be less switching and therefore more smoking-related deaths.
On the other side of the public health ledger, there is little reason to think that restricting information about ENDS, making them less cool, or banning e-liquid flavors would reduce morbidity and mortality among today's adolescents, either now or in the future. The FDA is alarmed that, according to the National Youth Tobacco Survey (NYTS), "more than 2 million middle and high school students were current users of e-cigarettes in 2017." But that number includes respondents who reported vaping at all during the previous month, even just once. The number of regular users is much smaller, and almost all of them are current or former smokers. The "epidemic" perceived by the FDA is mainly an epidemic of e-cigarette experimentation, and even that trend seems to have reversed, judging from the latest NYTS results.
To the extent that teenagers who otherwise would be smoking are vaping instead, that is an unambiguous gain in public health terms, since the latter habit is much less dangerous. Despite the constant warnings that increased experimentation with e-cigarettes would lead to more smoking, consumption of conventional cigarettes by teenagers stubbornly continues to decline, reaching a record low last year in the Monitoring the Future Study, which began in 1975. According to the NYTS, the incidence of past-month smoking among high school students fell from 15.8 percent in 2011 to 7.6 percent in 2017.
The ability of manufacturers to prevent underage consumption is, in any case, pretty limited. As long as some retailers are careless, some adults are willing to buy e-cigarettes on behalf of minors, and some teenagers manage to swipe them from parents or older siblings, there will be leakage from the adult market. If the FDA sees continued underage use as an argument for banning e-cigarettes, the industry is doomed, even though it offers what the agency recognizes as "an alternative for adult smokers who still seek access to satisfying levels of nicotine, but without all of the harmful effects that come from combustion."
The federal government is threatening to eliminate that alternative even while tolerating conventional cigarettes, which are far more hazardous and also end up in the mouths of people who are not old enough to buy them legally. If underage consumption does not justify a ban on tobacco cigarettes (and I don't think it does), it cannot possibly justify a ban on competing products that are much safer.
Gottlieb is remarkably cavalier about throwing adult smokers under the bus in the name of preventing adolescents from experimenting with e-cigarettes. "In enabling a path for e-cigarettes to offer a potentially lower risk alternative for adult smokers," he says, "we won't allow the current trends in youth access and use to continue, even if it means putting limits in place that reduce adult uptake of these products." Gottlieb would be on much firmer ethical ground if he took the opposite position: In trying to stop teenagers from vaping, we won't deny adult smokers access to products that could save their lives.